Reported Jul 27, 2022 · Terminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies…
Cipla
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CIPLA · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd
- byCipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd
- forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35
- Lot codes and dates
Batch# DEG4LC2exp. date 05/2023
- Amount recalled
- 8,136 bottles
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
This product could cause temporary or reversible health problems — stop using it.
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